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FDA Approves New Schizophrenia Data for Rexulti

The update adds an indication for maintenance treatment of schizophrenia

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved the labeling update for Rexulti (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia.

The approval of the labeling update was based on data from a long-term randomized withdrawal trial in adults aged 18–65 years with schizophrenia. After patients were cross-titrated from a prior antipsychotic to Rexulti and underwent a 12–36 week single-blind Rexulti stabilization phase, patients who were symptomatically stable on Rexulti for 12 consecutive weeks in the stabilization phase were randomized to a double-blind treatment phase to either Rexulti (n=97) or placebo (n=105).

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Relapse during the double-blind phase was established if patients met any of the following criteria: worsening symptoms defined by changes in PANSS or CGI-I scores; hospitalization for worsening psychotic symptoms; suicidal behavior, or violent/aggressive behavior.

An interim analysis showed a statistically significant longer time to relapse in patients who took Rexulti vs. placebo. This trial was terminated early because maintenance of efficacy was demonstrated. The final analysis showed a statistically significant longer time to relapse (hazard ratio [HR] 0.292; P<0.0001) in patients who took Rexulti vs. placebo. In addition, the proportion of subjects who met the criteria for impending relapse (secondary endpoint), was statistically significantly lower in Rexulti-treated patients vs. placebo group.

Rexulti, an atypical antipsychotic, is indicated as adjunct therapy for major depressive disorder (MDD), and for the treatment of schizophrenia. It is available as 0.25mg, 0.5mg,1mg, 2mg, 3mg, and 4mg strength tablets.